Multilevel HIV Prevention Strategy for Increasing PrEP Uptake

(STARR-NC Trial)

Overseen By Sarah E Rutstein, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: PrEP

Disqualifiers: HIV-positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

336 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new way to help people in rural and peri-urban North Carolina start using HIV prevention medication (PrEP). It includes personal help from a navigator, online educational resources, and telehealth services. The goal is to make it easier for people at STI clinics to get and use PrEP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be currently using PrEP to participate.

What data supports the effectiveness of the treatment HealthMpowerment Digital Health Intervention for increasing PrEP uptake?

Research shows that digital health tools, like mobile apps and online platforms, can effectively engage people in HIV prevention by providing real-time feedback and support, which may help increase adherence to PrEP (a medication to prevent HIV). ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for increasing PrEP uptake?

Research shows that digital health tools, like mobile apps and online services, can effectively engage people in HIV prevention and care, helping them stick to their medication schedules and access services more easily. These tools have been shown to improve adherence to PrEP, which is a medication taken to prevent HIV infection. ^{1 2 3 4 5}

Is PrEP safe for humans?

PrEP, which includes medications like Truvada (emtricitabine/tenofovir disoproxil fumarate), is generally considered safe for humans. It has been approved by the FDA and is used to prevent HIV infection, with studies focusing on improving adherence and uptake rather than safety concerns. ^{1 3 4 6 7}

Is PrEP generally safe for humans?

PrEP, which includes medications like Truvada (emtricitabine/tenofovir disoproxil fumarate), is FDA-approved and has been widely used to prevent HIV infection. While the studies focus on adherence and uptake, the approval and use of PrEP suggest it is generally considered safe for humans. ^{1 3 4 6 7}

How does the HealthMpowerment Digital Health Intervention for increasing PrEP uptake differ from other treatments for HIV prevention?

The HealthMpowerment Digital Health Intervention is unique because it leverages mobile health (mHealth) technology to increase PrEP uptake among men who have sex with men (MSM), particularly targeting adolescents and young adults who are avid technology users. This approach is novel as it combines digital tools with traditional prevention strategies, aiming to reach populations that may not be effectively served by existing urban outreach efforts. ^{5 8 9 10 11}

How does the HealthMpowerment Digital Health Intervention for increasing PrEP uptake differ from other treatments for HIV prevention?

The HealthMpowerment Digital Health Intervention is unique because it leverages mobile health (mHealth) technology to increase PrEP uptake among men who have sex with men (MSM), particularly targeting adolescents and young adults who are avid technology users. This approach is novel as it combines digital tools with traditional prevention strategies, aiming to reach populations not effectively covered by existing urban outreach efforts. ^{5 8 9 10 11}

Research Team

Sarah Rutstein, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals assigned male at birth, aged 18-39, who have had sexual activity with a male in the past year and are not currently using PrEP. They must speak English, have daily smartphone access, and have tested HIV-negative within the last 90 days.

Inclusion Criteria

I am between 18 and 39 years old.

Have daily smartphone access

I have been sexually active with a male in the last year.

Exclusion Criteria

Confirmed prior HIV-positive diagnosis

I have used PrEP medication in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina STI clinics

3 years

Baseline and quarterly follow-up assessments

Intervention

Participants in the intervention arm receive a multilevel intervention including a PrEP Navigator, Digital Health Intervention platform, and referral to Telehealth PrEP services

6 months

Quarterly follow-up assessments

Control

Participants in the control arm receive standard PrEP referral services and a limited version of the Digital Health Intervention platform

6 months

Quarterly follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Quarterly follow-up assessments

Treatment Details

Interventions

• HealthMpowerment Digital Health Intervention - Basic
• HealthMpowerment Digital Health Intervention - Enhanced
• PrEP Navigation Services
• Telehealth PrEP Services Referral

Trial Overview The study tests a strategy to increase PrEP use among participants. It includes randomized trials of PrEP Navigation Services, two versions of HealthMpowerment Digital Health Intervention (basic and enhanced), and Telehealth referrals over three years in rural North Carolina STI clinics.

Participant Groups

Group I: STARR NC Intervention Condition Experimental Treatment 3 Interventions

Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care. The Intervention Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center; Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement. Intervention Arm participants will complete baseline and quarterly follow-up assessments. Intervention Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

Group II: STARR NC Standard-of-Care Control Condition Active Control 1 Intervention

Standard-of-Care Control arm will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive study staff guided support to install the control arm version of the HealthMPowerment DHI platform. The Control Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center. Control Arm participants will complete baseline and quarterly follow-up assessments. Control Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

HealthMpowerment Digital Health Intervention - Basic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Truvada for:

• HIV pre-exposure prophylaxis

Approved in United States as Truvada for:

• HIV pre-exposure prophylaxis

Approved in Canada as Truvada for:

• HIV pre-exposure prophylaxis

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

A study involving 71 HIV-negative adults using a digital health feedback system with ingestible-sensor-enabled Truvada® showed that 88.7% of participants adhered to the medication for at least 28 days, with an average adherence rate of 86.2%.

Adherence patterns indicated that older age and negative methamphetamine screens were associated with better adherence, suggesting that substance use may negatively impact the effectiveness of oral PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. Browne, SH., Vaida, F., Umlauf, A., et al.[2023]

A systematic review of literature from 2013-2014 identified 23 published studies and 32 funded projects utilizing eHealth and mHealth strategies to enhance HIV prevention and care, indicating a growing trend in using technology for health interventions.

Despite the effective use of social media and other digital tools in engaging populations for HIV prevention, significant gaps still exist in ensuring patients are linked to care, retained in care, and initiated on antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. Muessig, KE., Nekkanti, M., Bauermeister, J., et al.[2022]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

The ePrEP clinic, which offers online self-sampling for HIV and STIs, online consultations, and remote medication provision, was found to be highly acceptable among 15 PrEP users and 9 healthcare professionals, suggesting it could enhance convenience and empower users.

While the ePrEP clinic could increase capacity in sexual health services, some users expressed concerns about the need for blood self-sampling, indicating that it may be best suited for established PrEP users with good digital health literacy and no significant medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering HIV prevention medication online: Findings from a qualitative study exploring the acceptability of an online HIV pre-exposure prophylaxis (PrEP) care pathway among service users and healthcare professionals. Kincaid, R., Gibbs, J., Dalrymple, J., et al.[2023]

Mobile health (mHealth) tools have the potential to significantly enhance HIV prevention strategies among adolescent and young adult men who have sex with men (MSM), a group particularly at risk for new infections.

Despite the promise of mHealth interventions, challenges remain in integrating these tools into existing public health programs, necessitating strategies to overcome barriers to implementation and scale-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile apps for HIV prevention: how do they contribute to our epidemic response for adolescents and young adults? Sullivan, PS., Hightow-Weidman, L.[2021]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

The mSMART mobile health intervention showed high feasibility and acceptability among 15 Black men who have sex with men (MSM) already prescribed PrEP, with an impressive 82% daily usage rate and positive feedback on user-friendliness.

Participants demonstrated improved PrEP adherence, as indicated by biomarker scores, suggesting that gamified interventions like mSMART could effectively enhance medication adherence and reduce barriers to taking PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. Mitchell, JT., Burns, CM., Atkinson, B., et al.[2023]

Emerging technologies, such as internet and smartphone-based solutions, have the potential to significantly enhance HIV prevention efforts by reaching at-risk populations, particularly rural men who have sex with men (MSM), who are often underserved by traditional outreach methods.

A successful HIV prevention strategy should combine technology-enabled services with personalized interventions, ensuring that both algorithmic and non-algorithmic approaches are utilized to effectively meet the diverse needs of target populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging technologies for HIV prevention for MSM: what we have learned, and ways forward. Sullivan, PS., Grey, JA., Simon Rosser, BR.[2021]

A pilot study involving 16 HIV-negative men who have sex with men (MSM) demonstrated that a digital pill system (DPS) is a feasible and acceptable method for measuring adherence to daily PrEP, with 92.2% of expected ingestions recorded accurately.

The DPS showed strong correlations between recorded adherence and actual drug levels in the blood, indicating its effectiveness in tracking PrEP use, which is crucial for preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. Chai, PR., Mohamed, Y., Bustamante, MJ., et al.[2023]

The MyChoices mobile app, designed to increase HIV testing and PrEP use among young men who have sex with men (YMSM), was found to be highly acceptable and feasible, with 94% of participants using it at least once during the study.

In a pilot study with 60 participants, those using the MyChoices app showed a 22% higher prevalence of HIV testing compared to standard care, suggesting potential benefits, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake and Acceptability of MyChoices: Results of a Pilot RCT of a Mobile App Designed to Increase HIV Testing and PrEP Uptake Among Young American MSM. Biello, KB., Daddario, SR., Hill-Rorie, J., et al.[2023]

To significantly reduce HIV incidence among men who have sex with men (MSM), a coverage of 40-50% for multiple primary prevention interventions, including preexposure prophylaxis, is necessary, but current coverage levels in the USA are insufficient.

Technology-based tools, such as mobile apps, have the potential to expand access to HIV prevention services for MSM, yet most existing apps are not specifically tailored for this population, highlighting a need for better-targeted solutions and sustainable funding to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Roles of Technology in Primary HIV Prevention for Men Who Have Sex with Men. Sullivan, PS., Jones, J., Kishore, N., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Delivering HIV prevention medication online: Findings from a qualitative study exploring the acceptability of an online HIV pre-exposure prophylaxis (PrEP) care pathway among service users and healthcare professionals. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Mobile apps for HIV prevention: how do they contribute to our epidemic response for adolescents and young adults? [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging technologies for HIV prevention for MSM: what we have learned, and ways forward. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Uptake and Acceptability of MyChoices: Results of a Pilot RCT of a Mobile App Designed to Increase HIV Testing and PrEP Uptake Among Young American MSM. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The Roles of Technology in Primary HIV Prevention for Men Who Have Sex with Men. [2020]